Oral Immunotherapy for Childhood Egg Allergy

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Consortium of Food Allergy Research

Criteria

Inclusion Criteria:

• Convincing clinical history of egg allergy

• Age 6 to 18 years, with a serum IgE [UniCAP] to egg > 5 kUA/L OR

• Age 5 to 6 years, with a serum IgE [UniCAP] to egg ≥ 12kUA/L

• Parent/guardian willing to provide informed consent

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• History of severe anaphylaxis to egg. More information on this criterion can be found in the protocol.

• Known allergy to corn

• Chronic disease requiring therapy (e.g., heart disease, diabetes). Participants who have asthma, atopic dermatitis, or rhinitis are not excluded.

• Participation in any interventional study for the treatment of food allergy in the 6 months prior to study entry

• Participant is on "build-up phase" of immunotherapy and has not reached maintenance dosing. Participants tolerating maintenance allergen immunotherapy are not excluded.

• Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.

• Inability to discontinue antihistamines for the initial day of escalation, skin testing, and OFC

• Omalizumab or other nontraditional forms of oral or sublingual allergen immunotherapy, immunomodulator therapy, or biologic therapy in the 12 months prior to study entry. Participants who have taken corticosteroids are not excluded.

• Investigational drugs 90 days prior to study entry or planned use of an investigational drug during the study period

• Pregnancy or breastfeeding